Sevelamer Carbonate

Product NDC
55154-8188
11-digit product format
551548188
Labeler code
55154
Product ID
55154-8188_738ad13e-5d31-4c10-ac9c-6cf4b8773ff8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA207179
Marketing category
ANDA
Marketing start
2017-08-17
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer Carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER CARBONATE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9YCX42I8IU
Rxcui749206

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-8188-0Sevelamer Carbonate1 in 1 BLISTER PACKTABLET, FILM COATED14
55154-8188-0Sevelamer Carbonate10 in 1 BAGTABLET, FILM COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8188SEVELAMER CARBONATE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20240608_61d073ec-51a4-48c7-8762-25fdd00fe6ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN61d073ec-51a4-48c7-8762-25fdd00fe6ac4
749206sevelamer carbonate 800 MG Oral TabletSCD61d073ec-51a4-48c7-8762-25fdd00fe6ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8188-05515481880010 BLISTER PACK in 1 BAG (55154-8188-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2017-08-170000-00-00NoNoCurrent